Position and Esophageal Pressure

NCT02816359 | Completed

• 1 other identifier: 69HCL16_0152
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Esophageal pressure measurements are used in moderate/severe Accurate Respiratory Distress SyndromeARDS patients in order to set ventilator settings. There might be variations of the measured value according to the patient position (0° vs 30°) at the time of measurements.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Position patient; Esophageal pressure

Outcome Measures

Primary Outcomes (1)

• Total End-expiratory esophageal pressure

  After end-expiratory pause on the ventilator, absolute value of the esophageal pressure is measured (in Head-bed position at 30° then in head-bed position at 0° )

  30min after change of position

Secondary Outcomes (3)

• End-inspiratory esophageal pressure

  30min after change of position

• Gastric pressure

  30min after change of position

• End-expiratory lung volume

  30min after change of position

Study Arms (1)

head-bed position

OTHER

Head-bed position at 0° for 30 minutes then head-bed position at 30° for 30 minutes

Other: head-bed position

Interventions

head-bed position OTHER

Head-bed position at 0° for 30 minutes then head-bed position at 30° for 30 minutes

head-bed position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Acute respiratory failure defined by PaO2/FIO2\< 300 mmHg or pH\<7,35 and pCO2\>45mmHg or Moderate or severe Accurate Respiratory Distress Syndrome ARDS defined by:
• New or worsening respiratory symptoms in the previous week.
• Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or Nodules
• Respiratory failure not fully explained by cardiac failure or fluid overload
• PaO2/FIO2\< 200 mmHg and PEEP ≥ 5 cm H2O and VT ≤6 ml/kg of Ideal Body Weight
• Patient intubated or tracheotomized and receiving mechanical ventilation
• Indication of esophageal measurement decided by the clinician

You may not qualify if:

• Contraindication to naso-gastric tube insertion :
• Recent gastro-duodenal ulcer
• Stage III esophageal varices
• Refractory intracranial hypertension
• Unstabilized spine fracture
• Surgical contraindication
• Burns on more than 20 % of the body surface
• Underlying disease with a life expectancy of less than one year
• Pregnant or breast-feeding patients
• Subject deprived of freedom, minor, subject under a legal protective measure
• Research team unavailability
• Lack of medical care plan

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Croix-Rousse

Lyon, 69004, France

Location

Related Publications (1)

• Mezidi M, Guerin C. Effect of body position and inclination in supine and prone position on respiratory mechanics in acute respiratory distress syndrome. Intensive Care Med. 2019 Feb;45(2):292-294. doi: 10.1007/s00134-018-5493-1. Epub 2018 Dec 7. No abstract available.

  PMID: 30535985 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Claude Guerin, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 28, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

FR (1)